SCDM CCDM Exam - Topic 3 Question 1 Discussion

Actual exam question for SCDM's CCDM exam

Question #: 1
Topic #: 3

[All CCDM Questions]

On a dose escalation study, the Data Manager notices one site has a much higher number of queries than other sites and most are older than 30 days. The Data Safety Monitoring Board will meet in three weeks. What should the Data Manager providing CRO oversight do?

ANotify the CRO's Clinical Leader about the concerns

BCall the site directly and ask the study coordinator about the concerns

CConsult the CRO's Lead Data Manager and the CRO's Project Leader

DIgnore it for now and check back next week

Show Suggested Answer

Suggested Answer: C

The correct action is to consult the CRO's Lead Data Manager and CRO's Project Leader (Option C) to ensure the issue is addressed through the appropriate oversight and escalation process.

According to the GCDMP (Chapter: Project Management and Communication), when a sponsor Data Manager identifies significant data management issues under CRO oversight --- such as aging queries or site performance disparities --- communication must follow the established governance and escalation pathway defined in the Scope of Work (SOW) and Data Management Plan (DMP).

Directly contacting the site (Option B) bypasses the CRO's chain of command and violates communication protocols. Notifying only the Clinical Leader (Option A) is insufficient, and ignoring the issue (Option D) jeopardizes the Data Safety Monitoring Board (DSMB) review timeline.

Therefore, Option C ensures a documented, collaborative approach to problem resolution within the contractual oversight structure.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 7.1 -- Oversight of CRO Data Management Activities

ICH E6 (R2) GCP, Section 5.2 -- Contract Research Organization Responsibilities

FDA Guidance for Industry: Oversight of Clinical Investigations -- Sponsor and CRO Roles and Communication Pathways

by Becky at Nov 19, 2025, 01:27 PM

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Stevie

9 hours ago

I think calling the site directly is a good move too.

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Evangelina

6 days ago

Option B might work, but calling the site directly could come across as confrontational. Better to go through the proper channels and get the CRO's input.

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Barb

11 days ago

Haha, "Ignore it for now and check back next week"? That's the kind of advice you'd expect from someone who's never worked in clinical trials before.

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Willard

16 days ago

Option D is a terrible idea. Ignoring it and checking back next week? That's just asking for trouble. Gotta be proactive on these things.

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Alpha

21 days ago

I agree with Ashley. Bringing in the CRO's leadership is the best way to address this issue properly.

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Ashley

26 days ago

Option C seems like the most appropriate action. Consulting the CRO's Lead Data Manager and Project Leader would ensure a coordinated and informed response.

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Glenn

1 month ago

Ignoring it seems risky, but I wonder if there's a chance the site is just catching up? I feel like option D is definitely not the right choice.

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Dana

1 month ago

I remember a similar question where we had to prioritize communication. I think notifying the Clinical Leader could help address the issue quickly, but I'm not confident.

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Melodie

1 month ago

I'm not entirely sure, but I feel like calling the site directly might be too informal. Maybe option A could be better to escalate the issue properly?

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Kanisha

2 months ago

Option C sounds like the way to go. Getting input from the Lead Data Manager and Project Leader will help ensure you're taking the right approach to address this before the upcoming meeting.

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Merri

2 months ago

I think I'd start by calling the site directly (option B) to get more information and understand what's causing the high number of queries and delays. That could help inform the next steps to take.

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Kate

2 months ago

Definitely notify the CRO's Clinical Leader about the concerns (option A). That seems like the most responsible thing to do, given the upcoming Data Safety Monitoring Board meeting. Can't ignore potential issues like that.

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Mila

2 months ago

Definitely should notify the CRO's Clinical Leader.

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Gracia

2 months ago

I think option C makes the most sense since consulting with the Lead Data Manager and Project Leader could provide a more comprehensive view of the situation.

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Adolph

2 months ago

I think option A is the best. Communication is key.

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Rikki

3 months ago

Hmm, I'm a little unsure about this one. There are a few different options, and I'm not sure which one is the best approach. I might need to re-read the question a few times to make sure I fully understand what's being asked.

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Gerry

3 months ago

This seems like a pretty straightforward data management issue. I'd probably go with option C and consult the CRO's Lead Data Manager and Project Leader to get their input and recommendations on how to handle it.

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Keneth

3 months ago

Communication is key! Let’s get everyone on the same page.

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Dorethea

3 months ago

Definitely! They’ll have the best insight on this.

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